Horiba Instruments recalls
Horiba Instruments appears in 28 official U.S. recall notices indexed by RecallRadar, most recently on 2024-07-10.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- HORIBA custom configured fluorescence instrument, modular Fluorolog-QM
FDA Device · Class II · 2024-07-10 · Horiba Instruments - Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944
FDA Device · Class II · 2019-10-16 · Horiba Instruments - ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure…
FDA Device · Class II · 2018-07-04 · Horiba Instruments - 10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400
FDA Device · Class II · 2018-02-07 · Horiba Instruments - 15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400
FDA Device · Class II · 2018-02-07 · Horiba Instruments - ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use
FDA Device · Class II · 2016-05-04 · Horiba Instruments - Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use
FDA Device · Class II · 2016-05-04 · Horiba Instruments - ABX PENTRA Triglycerides CP ref
FDA Device · Class II · 2016-02-10 · Horiba Instruments - ABX PENTRA Uric Acid CP ref
FDA Device · Class II · 2016-02-10 · Horiba Instruments - The ABX PENTRA Cholesterol CP ref
FDA Device · Class II · 2016-02-10 · Horiba Instruments - ABX PENTRA Glucose PAP CP ref
FDA Device · Class II · 2016-02-10 · Horiba Instruments - ABX PENTRA Enzymatic Creatinine CP ref
FDA Device · Class II · 2016-02-10 · Horiba Instruments - ABX PENTRA Lactic Acid CP ref
FDA Device · Class II · 2016-02-10 · Horiba Instruments - ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)
FDA Device · Class II · 2015-01-14 · Horiba Instruments - Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower Product Model #: D00A00224D The Lite DM (Lite Data Manager) is…
FDA Device · Class II · 2014-12-31 · Horiba Instruments - ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX PENTRA Magnesium RTU reagent with associated calibrators and contro…
FDA Device · Class II · 2014-10-01 · Horiba Instruments - Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction
FDA Device · Class II · 2014-03-19 · Horiba Instruments - ABX PENTRA Multical
FDA Device · Class II · 2014-03-12 · Horiba Instruments - ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions…
FDA Device · Class III · 2014-02-12 · Horiba Instruments - ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for t…
FDA Device · Class II · 2014-02-12 · Horiba Instruments - ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many cell functions: intracellularly in muscle contract…
FDA Device · Class III · 2013-10-02 · Horiba Instruments - HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Below
FDA Device · Class II · 2013-04-24 · Horiba Instruments - ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Compute…
FDA Device · Class III · 2013-04-10 · Horiba Instruments - ABX PENTRA ML, Software Versions: V8.0.x and Below
FDA Device · Class II · 2013-01-16 · Horiba Instruments - PENTRA C200, Part Number: A11A01629
FDA Device · Class II · 2013-01-09 · Horiba Instruments - ABX PENTRA AST CP, Part Number: A11A01629
FDA Device · Class II · 2013-01-09 · Horiba Instruments - Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High)
FDA Device · Class III · 2012-11-28 · Horiba Instruments - ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709
FDA Device · Class III · 2012-11-21 · Horiba Instruments